Healthcare Reform and FDA Updates

December 21, 2009

Highlights in healthcare reform and FDA transition, excerpted from recent national presentations by McGuireWoods’ Life Sciences Industry Group attorneys.

Healthcare Reform

  • The Senate cleared a set of key procedural hurdles on President Obama’s healthcare legislation early Tuesday with more party line votes, continuing the effort to pass the Senate’s version of the healthcare reform bill before Christmas.
  • All 60 senators who vote with the Democratic caucus (58 Democrats and two Independents) supported votes that set up a third and final 60-vote hurdle for Wednesday, while all Republican senators voted to block the action.
  • Senate Republicans have indicated they are likely to force the full 30 hours of debate allowed after cloture vote on each of three pieces needed to pass the bill – the manager’s amendment; the bill itself; and the underlying House measure (H.R. 3590) that the Senate is using as a vehicle for healthcare reform. Yesterday morning’s vote, followed by today’s vote, sets in motion a schedule proposed by the leadership that would see the Senate voting on the final component of the bill by around 9 p.m. Christmas Eve.
  • The manager’s amendment that was the subject of Monday morning’s vote is a 383-page package of changes to the bill compiled by Majority Leader Harry Reid (D-NV). The amendment includes several concessions to moderate Democrats, including dropping both the public option and the proposed alternative plan of allowing people age 55 and older to buy into Medicare. Sen. Ben Nelson (D-NE), who won tighter restrictions on insurance coverage for abortions as well as increased federal healthcare aid for his state, was the last senator to announce he would support the plan.
  • After the final vote in the Senate, the bill will have to be combined with the House bill before being sent to the president. As there are substantial differences between the two bills, this will likely be a difficult conference process. Speaker Nancy Pelosi (D-CA) has said that the House will not simply accept the Senate bill as is. Some moderate Senate Democrats have warned they could turn against the bill, if changes made during negotiations with the House move the bill too far left.
  • Governors are concerned about the Medicaid expansion proposed in the House and Senate versions of healthcare reform. They fear another unfunded mandate when state Medicaid spending is exploding already due to the recession-induced enrollment increases.

FDA Updates

  • Change: FDA is a living organization with the character of those who populate it. Overwhelming personnel changes spurred by the new administration and recent office moves have given the agency a new personality. Many new additions have joined from para-industry/political groups advocating for increased government regulation.
  • Vigorous Regulation: The pendulum has swung definitively away from yesterday’s hands-off policies, and FDA is part of the new wave of reaction to lack of oversight.
  • Stricter Scrutiny: A groundswell for a 510(k) process overhaul has been building for years, and “the Menaflex incident” broke the camel’s back. Expect the $1.3M Institute of Medicine study to be completed in 2011 to mirror FDA’s internal report finding a need for fundamental changes to intensify the 510(k) process. Immediately after the new year, expect major changes to the Special 510(k) “changes being effected” rule narrowing eligibility and broadening requirements for documentation.
  • Transparency & Definition: FDA processes will be clearer and more visible to intra- and extra-agency groups to increase efficiency.
  • Enforcement: This is the word of the day from FDA Commissioner Hamburg. FDA is using powers it has had for years but rarely, if ever, exercised: e.g., civil money penalties for MDR violations, criminal indictments of life science executives, pre-warning letter action if public health deemed threatened.
  • Opportunity: There is tremendous opportunity for nimble, creative, entrepreneurial operations to use FDA’s stated goals and conceded challenges to leverage beneficial outcomes. Now more than ever is the chance to craft individual solutions via assertive collaboration toward shared goals of innovation and public health.

Visit the Healthcare Reform section for additional updates and resources.